Back to resultsA Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension (CONTROL HTN-2)
Primary Purpose
Hypertension, High Blood Pressure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ROX Coupler
Sham procedure
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring Hypertension, High Blood Pressure, Systolic Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Vascular Disease
Eligibility Criteria
Inclusion Criteria:
- Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening.
Exclusion Criteria:
- Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.
Sites / Locations
- Cardiology P.C. Research
- UAB Division of Cardiovascular Disease
- The Cardiac and Vascular Institute Research Foundation
- Piedmont Heart Institute
- Prairie Education and Research Cooperative
- Cardiology Associates Research
- Northwell Health - North Shore University Hospital
- Northwell Health - Lenox Hill Hospital
- Duke University Hospital
- The Lindner Center for Research and Education at The Christ Hospital
- The MetroHealth System
- OhioHealth Research Institute
- CAMC Clinical Trials Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Treatment Group A
Control Group B
Arm Description
ROX Coupler implantation and continuing antihypertensive medications.
Sham procedure and continuing current antihypertensive medications.
Outcomes
Primary Outcome Measures
Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure
Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure at six month as compared to Baseline
Secondary Outcome Measures
Change in mean office systolic blood pressure
Change in mean office systolic blood pressure at six months as compared to Baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02895386
Brief Title
A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
Acronym
CONTROL HTN-2
Official Title
A Prospective, Randomized, Adaptive, Double-Blind, Sham-Controlled, Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Company/Sponsor has discontinued business
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ROX Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the safety and effectiveness of the ROX Coupler used to create an arteriovenous anastomosis in the iliac region (between the iliac artery and vein) in subjects with hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, High Blood Pressure
Keywords
Hypertension, High Blood Pressure, Systolic Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Vascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group A
Arm Type
Active Comparator
Arm Description
ROX Coupler implantation and continuing antihypertensive medications.
Arm Title
Control Group B
Arm Type
Sham Comparator
Arm Description
Sham procedure and continuing current antihypertensive medications.
Intervention Type
Device
Intervention Name(s)
ROX Coupler
Intervention Description
ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein).
Intervention Type
Other
Intervention Name(s)
Sham procedure
Intervention Description
Sham procedure + continuing current antihypertensive medications.
Primary Outcome Measure Information:
Title
Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure
Description
Change in mean 24-hour Ambulatory Blood Pressure Monitor systolic blood pressure at six month as compared to Baseline
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in mean office systolic blood pressure
Description
Change in mean office systolic blood pressure at six months as compared to Baseline
Time Frame
Baseline, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mean 24-hour ambulatory blood pressure monitoring (ABPM) SBP ≥ 140 mmHg at screening.
Exclusion Criteria:
Any serious medical condition that may adversely affect the patient's safety, limit the subject's ability to participate in the study, comply with follow-up requirements or impact the scientific integrity of the study.
Facility Information:
Facility Name
Cardiology P.C. Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
UAB Division of Cardiovascular Disease
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
The Cardiac and Vascular Institute Research Foundation
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Prairie Education and Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Facility Name
Cardiology Associates Research
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Northwell Health - North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Northwell Health - Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Lindner Center for Research and Education at The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
The MetroHealth System
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
OhioHealth Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
CAMC Clinical Trials Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25620016
Citation
Lobo MD, Sobotka PA, Stanton A, Cockcroft JR, Sulke N, Dolan E, van der Giet M, Hoyer J, Furniss SS, Foran JP, Witkowski A, Januszewicz A, Schoors D, Tsioufis K, Rensing BJ, Scott B, Ng GA, Ott C, Schmieder RE; ROX CONTROL HTN Investigators. Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial. Lancet. 2015 Apr 25;385(9978):1634-41. doi: 10.1016/S0140-6736(14)62053-5. Epub 2015 Jan 23. Erratum In: Lancet. 2016 Feb 13;387(10019):648. Lancet. 2015 Apr 25;385(9978):1622. Lancet. 2016 Feb 13;387(10019):648.
Results Reference
background
PubMed Identifier
29061728
Citation
Lobo MD, Ott C, Sobotka PA, Saxena M, Stanton A, Cockcroft JR, Sulke N, Dolan E, van der Giet M, Hoyer J, Furniss SS, Foran JP, Witkowski A, Januszewicz A, Schoors D, Tsioufis K, Rensing BJ, Scott B, Ng GA, Schmieder RE. Central Iliac Arteriovenous Anastomosis for Uncontrolled Hypertension: One-Year Results From the ROX CONTROL HTN Trial. Hypertension. 2017 Dec;70(6):1099-1105. doi: 10.1161/HYPERTENSIONAHA.117.10142. Epub 2017 Oct 23.
Results Reference
background
Learn more about this trial
A Multicenter Study to Evaluate the ROX Coupler in Subjects With Hypertension
We'll reach out to this number within 24 hrs